Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
1 other identifier
observational
39
1 country
1
Brief Summary
The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2021
CompletedOctober 4, 2021
October 1, 2021
1 year
April 23, 2019
October 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients having at least one Adverse Event (AE)
All AEs reporting
through study completion, an average of 1 year
Secondary Outcomes (5)
Clinical Global Impression of Improvement (CGI-I)
at Follow-up visit at 1, 3, 6, 9, 12 months
Parkinson Disease Questionnaire (PDQ-8)
at baseline, Follow-up visit at 6,12 months
Unified Parkinson's Disease Rating Scale (UPDRS)
at baseline, Follow-up visit at 6,12 months
Montreal Cognitive Assessment (MoCA)
at baseline, Follow-up visit at 6,12 months
Patients' Global Impressions of Change (PGI-C)
at Follow-up visit at 1, 3, 6, 9, 12 months
Study Arms (2)
Cohort 1
Standard of care (including L-DOPA) + starting opicapone
Cohort 2
Standard of care (including L-DOPA)
Interventions
Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.
Eligibility Criteria
The study plans to recruit approximately 100 elderly PD patients from neurology clinics
You may qualify if:
- Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
- Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary \[acquired or symptomatic\] Parkinsonism, Parkinson-plus syndrome)
- Patient with age \>=75 years at enrolment
- Patient with end-of-dose motor fluctuations suitable for additional treatment optimization
You may not qualify if:
- Patient concurrently participating in any clinical trial
- Patient who used tolcapone or opicapone previously
- For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
- Patient with any contraindications to Ongentys use
- Patient with any concomitant medical condition that could interfere with study assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norfolk&Norwich University Hospitals
Norwich, Norfolk, NR47UY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2019
First Posted
May 22, 2019
Study Start
April 28, 2020
Primary Completion
May 11, 2021
Study Completion
May 11, 2021
Last Updated
October 4, 2021
Record last verified: 2021-10